BUSINESS
Lupin's USFDA regulatory compliance woes may not augur well for US business revival
While an OAI classification doesn’t impact existing supplies and revenues from operations of this facility, but blocks new product approvals filed from the site. In addition it may even trigger a warning letter or import ban, if fails to satisfactorily address the concerns raised by USFDA.
BUSINESS
Pharma wrap: India's predicament of controlling patented anti-cancer medicine prices
The spiralling costs of patented cancer drugs has come to focus with governments in the developed and developing world grappling to deal with the problem.
BUSINESS
Pharma packaging firm Schott Kaisha rides on Indian drug companies' injectables push
The company which has two plants in Daman and Jambusar near Vadodara, and plans to add new manufacturing facilities in Daman and Baddi.
BUSINESS
Sun Pharma auditor files case against Macquarie with Economic Offences Wing: Sources
Macquarie, an Australian multinational independent investment bank and financial services company, questioned corporate governance practices at Sun Pharma, causing the drugmaker's shares to end at a six-month low on November 29, 2018.
BUSINESS
Govt trade margin cap falls short of curbing prices of most cancer drugs, but highlights trade distortion
The government said this is just a pilot, indicating that it may extend trade margin rationalization to other drugs as well.
BUSINESS
Piramal's contract manufacturing arm eyes US generics business via partner-led model
“We are a solution partner. We leverage our contract development and manufacturing (CDMO) capabilities, we work on the R&D and manufacturing of the product, and the partner takes care of distribution,” Vivek Sharma CEO of Piramal Pharma Solutions.
BUSINESS
Everstone Group picks stake in Chennai-based medical devices maker CPC Diagnostics
With this strategic investment, Everlife plans to support CPC’s manufacturing and distribution capabilities within India and South-East Asia, to become the leading IVD distributor in the region.
BUSINESS
L&T poised to meet FY19 order inflow guidance on pre-election boost
L&T needs around Rs 42,000 crore in the fourth quarter to meet the FY19 guidance.
BUSINESS
Bharat Biotech's Zika, Chikungunya vaccines to enter Phase II trials; focus now on private label market
So far there are no vaccines in the world against Zika and Chikungunya.
BUSINESS
This week in pharma: MMR vaccine and autism link refuted; Facebook clamps down hard on misinformation
The anti-vaccine movement never fully abated, but subsided largely due to evidence of vaccines as effective tools in improving public health.
BUSINESS
Opto Circuits to pare debt by raising funds from PE investors and asset sale
After a three-year slide in business, Opto Circuits was able to stymie losses with a profit of Rs 35 crore and revenues of Rs 225 core in FY18.
BUSINESS
Amid tough times, private hospitals face shortage of CEOs
The rapid expansion of private healthcare facilities over last one decade, has not just created shortage of specialist doctors but qualified senior administrators to manage them.
BUSINESS
Commissioner Scott Gottlieb exits USFDA, Indian firms curious on agency's future course
Actions by the US drug regulator impacts Indian manufacturers, who generate significant revenue by selling copycat drugs at a fraction of the cost in the world's largest market for medicines
BUSINESS
American PE firm's investment proposition to rich Indians: Assured returns, repayment guarantee and a EB-5 visa
With EB-5 opening up access to cheap long-term funds, US private equity and real estate firms are increasingly chasing investors in Asian countries such as China, India, Vietnam and South Korea.
BUSINESS
Novartis leads the way in using data and AI to find new drugs, improve R&D productivity
One of the initiative Data 42, called as ‘moonshot’ project within Novartis, is trying to harness the power of data analytics, machine learning and AI to possibly find leads for new drugs, new patient approaches and identifying safety features, by wringing new insights out of old clinical trials data.
BUSINESS
Lupin's Nilesh Gupta says new launches will help turn the corner in coming quarters
Lupin is hoping to turn the corner in the US, led by key approvals of generic versions of Renexa and Synthroid in place and a possible launch of Albuterol MDI in second half of FY20.
BUSINESS
Weekly wrap: Indian pharma loses its powerful voice with demise of DG Shah
Shah who was well networked, understood the IPR, trade, regulatory and drug pricing policies in depth, was a natural leader to lead the Indian pharmaceutical industry.
BUSINESS
Indian drug makers show improvement in USFDA inspection outcomes
According to USFDA data, out of 174 inspections in 2018 only 4 percent inspections are classified as OAI, attracting agency’s regulatory and administrative action such as withholding new approvals, warning letter and import alert, in contrast to 15 percent in 2017.
BUSINESS
China's Fosun to expand Gland Pharma operations in India
Frank Yao, Co-Chairman, Fosun Pharma who was in India, told Moneycontrol that the integration process of Gland Pharma with Fosun is over, and Fosun has plans to expand manufacturing footprint and add more products to the pipeline.
INDIA
Govt caps trade margins of 42 cancer drugs
Currently, 57 anti-cancer drugs are under price control as scheduled formulations.
BUSINESS
CDSCO to consider waiving off clinical trials for orphan drugs
While currently there is no definition on orphan drugs in India, medicines that are used in treatment rare diseases, with less than five lakh patients, typically fall under this category.
BUSINESS
Manipal Hospitals-Medanta deal will take more time to close, says top executive
Manipal, led by Ranjan Pai, was in race to buy Fortis Healthcare last year, but Malaysia’s IHH Healthcare outbid their rivals to buy the troubled healthcare provider.
BUSINESS
Pharma weekly wrap: USFDA lifts warning on Dr Reddy's Duvvada unit, relief after Bachupally observations
Duvvada resolution is expected to give a huge fillip to the company, as around 20% of its future ANDA (abbreviated new drug applications) filings were made from this facility.
BUSINESS
Aster DM to build budget hospitals in Gulf to meet demand from insured workers
In an exclusive interview over phone from Dubai, Moopen told Moneycontrol that insurance coverage to workers increased volumes but also put pressure on margins, as insurance companies now started pushing for steep discounts on package rates.
